Cleared Traditional

Infinity Acute Care System (IACS) Monitoring System (K203088) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203088 · Draeger Medical Systems, Inc. · Cardiovascular device
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Feb 2022
Decision
476d
Days
Class 2
Risk

K203088 is an FDA 510(k) clearance for the Infinity Acute Care System (IACS) Monitoring System. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Draeger Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on February 1, 2022 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Draeger Medical Systems, Inc. devices

Submission Details

510(k) Number K203088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2020
Decision Date February 01, 2022
Days to Decision 476 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
351d slower than avg
Panel avg: 125d · This submission: 476d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 160
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K203088.
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
K213234 · Ge Medical Systems Information Technologies, Inc. · Apr 2022
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
K213490 · Ge Medical Systems Information Technologies, Inc. · Apr 2022
Patient Information Center iX
K211900 · Philips Medizin Systeme B?blingen GmbH · Mar 2022
Infinity Acute Care System (IACS) Monitoring Solution
K201764 · Draeger Medical Systems, Inc. · Dec 2021
IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
K210906 · Philips Medizin Systeme Boeblingen GmbH · Oct 2021
Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
K203435 · Nihon Kohden Corporation · Jul 2021